Pharmaceutical Good Manufacturing Practice Regulations Article 87
Manufacturers shall review the requirements related to the product. This review shall be conducted prior to the manufacturers' commitment to supply a product to the customer and shall ensure the following:(1) Product requirements are defined and documented;(2) Contract or order requirements differing from those previously expressed are resolved; and(3) Manufacturers have the ability to meet the defined requirements.Records of the results of above review and actions arising from the review shall be maintained.Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by manufacturers before acceptance.Where product requirements are changed, manufacturers shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
中文原文 藥物優良製造準則第87條
製造業者應審查與產品有關之要求。
製造業者應在承諾供應顧客產品前執行審查，且應確保下列事項：
一、明文規定產品要求。
二、解決合約或訂單要求與先前表達相異之處。
三、製造業者有能力符合所規定之要求。
前項審查結果及由審查衍生措施之紀錄應予以維持。
當顧客提供非書面敘述之要求時，製造業者應在接受前確認顧客之要求。
當產品要求變更時，製造業者應修訂文件，確保相關人員已瞭解所變更之要求。
製造業者應在承諾供應顧客產品前執行審查，且應確保下列事項：
一、明文規定產品要求。
二、解決合約或訂單要求與先前表達相異之處。
三、製造業者有能力符合所規定之要求。
前項審查結果及由審查衍生措施之紀錄應予以維持。
當顧客提供非書面敘述之要求時，製造業者應在接受前確認顧客之要求。
當產品要求變更時，製造業者應修訂文件，確保相關人員已瞭解所變更之要求。